NCT02718664已完成不适用
Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition
研究概览
简要总结
Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer; not known with cancer or current treatment for cancer
- •Age at least 18 years
- •Able and willing to give written informed consent
- •Able and willing to consume the prescribed breakfast
- •Able and willing to undergo blood sampling
排除标准
- •Any treatment with investigational drugs within 30 days before the start of the study
- •Any condition that may interfere with the study protocol
- •Women who are pregnant
- •Allergies or intolerance for components of the prescribed breakfast
研究组 & 干预措施
A (fasting)
No Intervention
Fasting condition
B (fed)
Experimental
Fed condition (test meal)
干预措施: Test meal (breakfast) (Other)
结局指标
主要结局
Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition
时间窗: 2 test days
12 blood samples taken on both test days (fed and fasting condition), to investigate the effect of food on uracil and dihydrouracil levels
次要结局
- dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h)(baseline)
研究者
研究点 (1)
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